Aikins 2010.
Methods | Single‐centre RCT. University Hospital, Texas, USA | |
Participants | 20 obese patients BMI > 27.5 kg/m2. Unclear whether patients undergoing surgery. Inclusion criteria: ASA II to III. Exclusion criteria: ASA IV to V Mean BMI (SD): FIS 32 (2.5); intubating SAD 34 (7); VLS 35 (4.5); stylet 34 (7) Mean age (SD): FIS 48.4 (16); intubating SAD 46.8 (9); VLS 40 (17); stylet 43 (14) |
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Interventions | Four intervention groups. Five participants randomly assigned to each of the following.
“Following insertion the cuff was inflated with 25‐40 ml of air and manual ventilation attempted. Tidal volumes >10 ml/kg, adequate movement of the chest wall and over 15 cm H2O airway pressure were judged acceptable ventilation. Only one attempt at blind intubation through the Fastrach™ with the silicone ett was undertaken. If unsuccessful, one attempt at fibreoptic bronchoscope guided tracheal intubation through the Fastrach™ was allowed”
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Outcomes | Failed intubation.
Complications such as mucosal bleeding injury, hoarseness, dental injury, sore throat, difficult or painful swallowing assessed by participant review on POD0 and POD1 Time of insertion of test device into oropharynx to manual ventilation through TT |
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Details of anaesthetic induction and intubation | Rapid sequence induction Preoxygenation for three to five minutes; general anaesthesia was induced intravenously with 1 to 2 mg/kg propofol, 1 to 3 mcg/kg fentanyl and 1 mg/kg succinylcholine IV. After induction, cricoid pressure was maintained and mask ventilation verified. In all groups, an appropriately sized tracheal tube (TT) for oral intubation was chosen (inner diameter 7.5 to 8.0 mm in males and 7.0 to 7.5 mm in females) NBMA: 1 mg/kg succinylcholine |
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Training and seniority of intubator | Novice intubator (physician anaesthetist). Ten months' experience with direct laryngoscopy Viewed instructional videos and received didactic instruction on four devices. No more than five practical experience with devices |
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Notes | Statement indicating no sources of support and no conflicts of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants randomly assigned—no further details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) Failed intubation, first success, ease of intubation and time for intubation | High risk | No mention of blinding |
Blinding of participants and personnel (performance bias) Patient‐reported outcomes | Unclear risk | No details of how participants were treated after surgery and of pain relief, etc, given. Unclear whether recovery staff were blinded |
Blinding of outcome assessment (detection bias) Failed intubation, first success, ease of intubation and time for intubation. | High risk | No mention of blinding |
Blinding of outcome assessment (detection bias) Patient‐reported outcomes | Unclear risk | Not clear whether participant blinded. No standardized instruments described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All outcomes prespecified in Methods |
Other bias | Low risk |